Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02422446
Recruitment Status : Terminated (Difficulty enrolling patients with elevated triglycerides under statin treatment)
First Posted : April 21, 2015
Results First Posted : June 6, 2018
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Luc Djousse, Brigham and Women's Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This pilot trial seeks to obtain preliminary data on the effects of eicosapentaenoic acid (EPA) (4g/d) on endothelial function measured via endopat2000 after 12 weeks of intervention among adults with elevated triglycerides and type 2 diabetes.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Coronary Artery Disease Drug: Icosapent ethyl Phase 3

Detailed Description:
Thirty adults aged 30-75 y will be randomized to either 4 g/d of eicosapentaenoic acid or no drug for 12 weeks. Endothelial function will be measured at baseline and after 12 weeks. in a secondary aims, we will evaluate effects of eicosapentaenoic acid (EPA) on plasma levels of c-reactive protein, oxidized low-density lipoprotein cholesterol, and endothelin-1.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects: A Pilot Trial
Study Start Date : April 2015
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : March 1, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: EPA arm
EPA arm will receive 4 grams per day of EPA (icosapent ethyl) taken twice a day
 Drug: Icosapent ethyl
icosapent ethyl is eicosapentaenoic acid, an omega-3 fatty acid that naturally occurs in fish
Other Names:
  • Vascepa
  • Eicosapentaenoic Acid
  • EPA
No Intervention: Control
Control group will not receive EPA


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change From Baseline in Endothelial Function at 12 Weeks Using Reactive Hyperemia Index (RHI) [ Time Frame: Between baseline and 12 weeks ]
    Change in endothelial function between baseline value and 12-week value


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 30+ years
  • Hypertriglyceridemia (150-400 mg/dl)
  • Statin use for at least six months at the time of screening
  • Type 2 diabetes treated with diet and/or oral hypoglycemic agents diagnosed 1+ year
  • Ability to provide informed consent and provide blood samples
  • Willingness to abstain from fish oil, EPA, over the counter niacin, and other omega-3 fatty acid supplements during the study period (12 weeks)
  • Ability to travel to the study site at Brigham and Women's Hospital for 3 study visits
  • Reactive hyperemia index (RHI) of ≤ 2.0

Exclusion Criteria:

  • Eating disorder or heavy drinkers
  • Treatment with chronic prescription pharmacotherapy for metabolic or cardiovascular disease management or risk factor modification
  • Pregnant or lactating women
  • Statin use <6 months at the time of screening
  • Allergy to EPA, fish oil, or other omega-3 fatty acids
  • Current use of insulin, cyclophosphamide, estrogen, fibrates, niacin, hormone replacement therapy, testosterone, oral contraceptives, growth hormones, insulin-like growth factor-1, and other systemic steroids.
  • Inability to provide informed consent or blood samples
  • History or prevalent diagnosis of cancer, asthma, kidney insufficiency, stroke, seizures, allergic disorders, or congestive heart failure
  • Diagnosis of diabetes < 1 year prior to enrollment
  • Intention to move out of greater Boston area within one year
  • Current use of omega-3 supplements, fish oil, or >2 servings of fish per week
  • Bleeding disorder or uncontrolled endocrine (i.e., thyroid) or metabolic disorders
  • Treatment with blood thinning drugs (i.e. warfarin and clopidogrel)
  • Major surgical operation 3 months before or after screening
  • Organ transplantation
  • Current participation in another trial or plan to do so during the study
  • Inability to give informed consent or to travel to the study center at Brigham and Women's Hospital
  • RHI of >2.0
  • Triglycerides <150 mg/dl or >400 mg/dl
  • Body mass index of 40+ kg/m2
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02422446


Locations
Layout table for location information
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120
Sponsors and Collaborators
Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Luc Djousse, Brigham and Women's Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] February 22, 2016
Informed Consent Form  [PDF] May 28, 2015

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Luc Djousse, Director of Research, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02422446    
Other Study ID Numbers: 2013D003968
First Posted: April 21, 2015    Key Record Dates
Results First Posted: June 6, 2018
Last Update Posted: June 6, 2018
Last Verified: May 2018
Keywords provided by Luc Djousse, Brigham and Women's Hospital:
Endothelial function
Eicosapentaenoic acid
Triglycerides
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Eicosapentaenoic acid ethyl ester
Platelet Aggregation Inhibitors
Lipid Regulating Agents